Preliminary Study of Fish Oil and Dementia

NCT00628017 | Completed

• 1 other identifier: DOH-92-TD-1095
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This preliminary study is aimed to investigate whether it is feasible to conduct a study to use fish oil compared to the placebo(olive oil) in people with cognitive impairment. We will also explore whether fish oil has better efficacy in some clinical aspects in people with cognitive impairment during 24 weeks intervention. The major clinical outcome will be:

1. 1.general clinical impression
2. 2.cognitive function

Conditions

Alzheimer's Disease; Mild Cognitive Impairment

Keywords

polyunsaturated fatty acids; Alzheimer's disease; mild cognitive impairment; fish oil; cognition

Outcome Measures

Primary Outcomes (2)

• the Clinician's Interview-Based Impression of Change Scale (CIBIC-plus)

  24 weeks

• the cognitive portion of the Alzheimer's Disease Assessment Scale (ADAS-cog)

  24 weeks

Secondary Outcomes (3)

• Mini Mental Status Examination (MMSE) scores

  24 weeks

• 17-item Hamilton Depression Scale (HDRS)

  24 weeks

• adverse events

  24 weeks

Study Arms (2)

1

EXPERIMENTAL

omega-3 PUFAs(180mg eicosapentaenoic acid\[EPA\] + 120mg docosahexaenoic acid\[DHA\]/capsule), 3 capsules twice daily, total daily omega-3 fatty acid dosage of 1080 mg of EPA and 720 mg of DHA

Dietary Supplement: omega-3 polyunsaturated fatty acids ( EPA+DHA)

2

PLACEBO COMPARATOR

three identical placebo capsules twice daily which contained olive oil esters.

Dietary Supplement: omega-3 polyunsaturated fatty acids ( EPA+DHA)

Interventions

omega-3 polyunsaturated fatty acids ( EPA+DHA) DIETARY_SUPPLEMENT

Group 1 received omega-3 PUFAs as 3 capsules twice daily (total daily omega-3 fatty acid dosage of 1080 mg of EPA and 720 mg of DHA). Group 2 received three identical placebo capsules twice daily which contained olive oil esters. Identical gelatin capsules were used. Both treatment and placebo capsules were vacuum deodorized and supplemented with tertiary-butyl hydroquinone, 0.2 mg/g, and tocopherols, 2 mg/g, as antioxidants. The source of the omega-3 fatty acids was menhaden fish body oil concentrate.

Also known as: fish oil, n3 fatty acids

1; 2

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• fulfilled the diagnosis of AD according to the American Psychiatric Association, DSM-IV criteria, with mild or moderate severity( defined by an Mini Mental Status Examination (MMSE) score between 10 and 26, and a Clinical Dementia Rating (CDR) score of 1 or 2.)
• or amnesic MCI( defined as (1). Subjective memory impairment by the patient and /or an informant, (2) objective memory impairment falling at least 1.5 standard deviations or more below age- and education-specific norms on the Logical Memory delayed-recall score from the Wechsler Memory Scale III (3) relatively normal performance in other cognitive domains, (4) no impairment in activities of daily living, and (5) failure to meet DSM-IV criteria for dementia.)

You may not qualify if:

• inadequate motor or sensory capacity to comply with testing
• any ischemic lesion on brain CT reported by the radiologist or a modified Hachinski Ischemic Scale score \>4
• a 17-item Hamilton Depression Scale (HDRS)score \> 13
• abnormal levels of folic acid, vitamin B12, or thyroid function
• severe comorbidity, including another neurodegenerative diseases, another chronic debilitating neurological illness (e.g. cerebral palsy), brain trauma, tumors, severe pulmonary, renal, liver disease, cardiac disease, or autoimmune disease, or conditions expected to cause death within one year.
• Participants with a diagnosis of alcoholism, schizophrenia, and bipolar disorder were excluded.
• Participants receiving cholinesterase agents during the screen or taking NSAID on a long-term basis

Sponsors & Collaborators

• Taipei City Psychiatric Center, Taiwan: lead
• Department of Health, Executive Yuan, R.O.C. (Taiwan): collaborator

Study Sites (1)

Taipei City Psychiatric Center, Taipei City Hospital

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

Docosahexaenoic Acids; Fish Oils

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Oils

Study Officials

• Chih-Chiang Chiu, M.D.

  Department of Psychiatry, Taipei Psychiatric Center, Taipei City Hospital, Taipei, Taiwan

  PRINCIPAL INVESTIGATOR

• Shih-Yi Huang, PhD.

  School of Nutrition and Health Sciences, Taipei Medical University, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 24, 2008
• First Posted: March 4, 2008
• Study Start: January 1, 2003
• Primary Completion: March 1, 2005
• Study Completion: March 1, 2005
• Last Updated: March 4, 2008

Record last verified: 2008-02

Locations

TW (1)